IMPACCT: Infrastructure for Musculoskeletal Pediatric Acute Care Clinical Trials

摘要 两种常见上肢损伤的处理，小儿内上髁骨折（MEF） 桡骨远端移位骨折（DRF），是有争议的高度实践的变化。辩论主要是 重点是是否减少这些伤害，以恢复他们的正常位置，或让骨折愈合， 简单固定受伤部位观察性研究支持还原和简单 用于MEF和DRF的固定化。在这两种损伤中，很少有前瞻性研究，也没有随机研究 评估他们的待遇。鉴于实践中的广泛差异，儿童要么经历 当外科医生选择在麻醉/清醒状态下复位时，不必要的手术和麻醉事件 镇静或简单固定治疗不足。这两种情况都是不可接受的，因为儿童 面临麻醉风险和额外费用，或与潜在的长期功能残疾不一致 为了解决这些临床难题，肌肉骨骼儿科急症护理临床基础设施 组织了一个试验（IMPACCT）联合会，以发展必要的基础设施和经验， 多中心随机临床试验。IMPACCT的领导层在领先的多中心临床试验方面拥有专业知识 其成员来自北美儿科矫形学会的32个不同的中心 （POSNA）。在IMPACCT共识会议期间，与会者一致认为，多边环境论坛和发展成果框架具有 平衡是必要的，也是最紧迫的临床争议。一项类似的优先事项设定研究， 英国将这些问题确定为儿童骨科手术中的重要争议。 POSNA范围内的调查证实了MEF和DRF治疗的变化以及外科医生的随机化意愿。 需要对MEF和DRF儿童进行多中心随机优效性试验，以评估 麻醉/镇静下复位与单纯制动的临床有效性。核心假设 这一建议的一个重要方面是，儿童在全身麻醉（MEF）或清醒镇静下接受复位治疗， (DRF)患者报告的结局评分高于单纯制动治疗的患者 一个人两种裂缝的试验将同时进行，以利用规模经济， 在解剖位置、结果测量以及是否需要干预方面相似。三十- 一个研究中心同意根据实用性原则招募、随机分配和治疗共计688例患者， 协议.研究人员与审判创新网络合作，以提高审判效率 开发和执行。NIAMS已授予该倡议R34临床试验规划补助金。这 提案将支持患者招募、治疗和随访的主动研究阶段， 分析和传播结果。 这些试验的完成将为今后的工作提供一个框架、基础设施和经验。 前瞻性多中心临床试验在儿科骨科作为其结果指导临床决策。

ABSTRACT The management of two common upper extremity injuries, pediatric medial epicondyle fractures (MEF) and displaced distal radius fractures (DRF), is controversial with high practice variation. The debate largely focusses on whether to reduce these injuries to restore their usual position or to allow the fractures to heal in their injured position with simple immobilization. Observational studies support both reduction and simple immobilization for MEF and DRF. In both injuries, there have been few prospective and no randomized studies evaluating their treatment. Given the widespread variation in practice, children are either undergoing unnecessary procedures and anesthetic events when surgeons opt for reduction under anesthesia/ conscious sedation OR are being undertreated by simple immobilization. Both scenarios are unacceptable in that children face either anesthetic risks and extra costs or poor alignment with potential long term functional disability To address such clinical dilemmas, the Infrastructure for Musculoskeletal Pediatric Acute Care Clinical Trials (IMPACCT) consortium was organized to develop the infrastructure and experience necessary for multicenter randomized clinical trials. IMPACCT’s leadership has expertise in leading multicenter clinical trials and its members represent 32 diverse centers from the Pediatric Orthopaedic Society of North America (POSNA). During the IMPACCT Consensus Conference, participants agreed that that MEF and DRF have the equipoise necessary and are the most pressing clinical controversies. A similar priority-setting study from the United Kingdom identified these questions as important controversies in children’s orthopaedic surgery. POSNA-wide surveys confirmed MEF and DRF treatment variation and surgeons’ willingness to randomize. A multicenter randomized superiority trial of children with MEF and DRF is required to evaluate the clinical effectiveness of reduction under anesthesia/sedation vs. simple immobilization. The central hypothesis of this proposal is that children treated with reduction under general anesthesia (MEF) or conscious sedation (DRF) will have higher patient reported outcome scores compared to those treated with simple immobilization alone. Trials on both fractures will be conducted simultaneously to take advantage of the economy of scale and are similar in terms of anatomic location, outcome measures, and whether an intervention is necessary. Thirty- one sites have agreed to recruit, randomize and treat a total of 688 patients according to the pragmatic protocols. Investigators have partnered with the Trial Innovation Network to increase the efficiency of trial development and execution. NIAMS has awarded this initiative an R34 Clinical Trials Planning Grant. This proposal will support the active study phase when patients are recruited, treated, and followed and when results are analyzed and disseminated. The completion of these trials will provide a framework, infrastructure and experience for future prospective multicenter clinical trials in pediatric orthopaedics as its results guide clinical decision-making.